System, apparatus, and method for follicular unit extraction

ABSTRACT

Disclosed herein is a system, method, and apparatus for harvesting follicular units from an epidermis. The disclosed apparatus includes a hollow tubular structure having a central axis and a trumpet bell structure that is attached to an end of the hollow tubular structure. The trumpet bell structure terminates at a flat annular face that is substantially in a plane perpendicular to the central axis. The flat annular face has a sharp outer edge, and an inner surface of the trumpet bell structure inward from the flat annular face is smoothly varying.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to Belgian Patent ApplicationNo. 2016/0123, filed Jul. 5, 2016, the entire contents of which arehereby incorporated by reference herein.

FIELD OF THE INVENTION

The disclosed technology relates to systems, apparatus, and methods forharvesting all or part of hair follicles, commonly referred to asfollicular units.

BACKGROUND

During the past fifteen years, an original technique for harvesting hairgrafts for performing hair grafts was developed by Dr. R. Woods, Dr. R.Bernstein and Dr. W. Rassman as well as many pioneers which include Dr.J. Cole, Dr. Jones, Dr. P. Rose, Dr. J. Harris, etc. This techniqueconsists of using a sharp micro-tube, driven down around a smallgrouping of hairs called follicles. The maneuver is what is commonlycalled a scoring and is known as “FUE” which stands for Follicular UnitExtraction.

The skin is composed of two distinct parts-firstly the epidermis, whichis superficial and elastic but strong and very difficult to penetratewithout the help of a sharp instrument, and secondly a dermal part,which is deeper and looser and more easily dissected using a bluntinstrument.

The technique using sharp extraction instruments (referred to as “sharppunches”) is typically a two-step technique. Step 1 consists of pushingthe punch around the hairs composing the follicle. Step 2: When thefollicle is partially detached from the surrounding tissue, it ispossible to extract it by grasping it by its tip. This maneuvercorresponds to the actual follicular extraction.

The first method chosen by the majority of practitioners is to usesharp, even ultra sharp punches. The reasoning is as follows: thesharper the punch, the less it will deform the follicle within the skinduring step 1 of the follicular extraction.

The majority of the punches commercially available at present are thussharp or very sharp. There are many examples of these punches includingthe following references:

Restoration Robotics

-   -   U.S. Pat. No. 8,211,116 B2

Dr. John Cole

-   -   US 20070156164 A1    -   U.S. Pat. No. 9,204,892 B2    -   WO 2007/087463 A2

Dr. Sanusi Umar

-   -   US 20110160746 A1

Dr. James Harris

-   -   US 20100114118 A1    -   WO 2015/006658 A2

They all have the particularity of ending with a tapered triangular end,which is very aggressive. The sharp part is always directed in the sameaxis as the central axis of the tube, which is also the axis along whichthe punch moves, as shown in, for example, FIG. 2 illustrating punchesaccording to Cole and Artas.

The practitioner, however, faces a major insoluble problem with sharppunches. Indeed, the follicles almost always have the followingcharacteristic: they are arranged in the shape of a cone. The upper endof the cone corresponds to the output of the hair at skin level whileits lower base corresponds to the follicular zone of these hairs, asshown in FIG. 1.

On the other hand, the follicle is firmly attached to surroundingstructures. To be able to detach a follicle in order to extract itwithout damage (Step 2), the punch must be pushed in deep enough; thatis to say about 3-4 mm below the epidermis. Given the conical shape ofthe follicle, the result of using sharp punches is oftentransection—that is to say, the full section of one or more of the hairsremaining captive in the donor zone. This has the effect of reducing thenumber of transferred hairs and thereby reducing the quality of thesurgical intervention.

The orientation of the sharp punch is also crucial. Indeed, theslightest deviation from the axis of movement causes contact between thecutting portion and the hair, which causes at best a superficialabrasion, called paring, and at worst a full section of hair remainingin the donor zone, called a transection.

Consequently, it is often necessary to reduce the depth of the incisionmade with a sharp punch, such as limiting the incision depth to 2 mmbelow the epidermis, and/or to increase the diameter of the punch toobtain grafts with a low transection rate. This has the effect ofincreasing the size of scars and of damaging the follicles adjacent tothe one being extracted. Furthermore, when a sharp punch only slightlypenetrates the dermis, the extraction process (Step 2) is slowed with arisk of damaging the follicles during extraction. So this lengthens theoverall duration of the intervention.

Numerous specific systems to limit the depth of insertion of sharppunches have been proposed. For example, Dr. John Cole has developedsuch systems on all of his follicular extraction instruments.

Even so, it is common to find that despite the efforts of practitioners,the rate of removed follicles that are damaged or completely cut isoften significant and sometimes enormous. It is not uncommon to findharvests with more than 20 to 40% of damaged hairs or follicles.

The second method developed about 15 years ago has been to subdivideStep 1 into two steps with the use of two different punches. This secondmethod was named the “3 step” technique. The first step is the verysuperficial cutting of the epidermis with the aid of a sharp punch. Thesecond step is to then use a blunt or dull punch to dissect the dermaltissue around the hairs without damaging them. And the third step is theactual extraction. The technique dates from 2004 and was invented by Dr.James Harris. FIG. 3 illustrates an example of Dr. Harris' instrument.

This same principle was adopted by the Restoration Robotics Company,which still currently uses a system consisting of two punches on itsArtas robot-one sharp punch is enclosed in a blunt punch that slidesaround it, as shown in FIG. 4. The two punches work successively.

There are disadvantages to the two-step technique and the 3-steptechnique. Accordingly, there is continued interest in development ofimproved follicular extraction instruments.

SUMMARY

The present invention relates to a device and a method for harvestingall or part of follicles commonly called follicular units. The discloseddevice includes a hollow tube-like punching tool suitable for producingcores in the scalp. In one embodiment, the tool has a flat endsubstantially perpendicular to the tube central axis, with the flat endterminating in a sharp external cutting edge. The interior of the tubeis rounded similar to the shape of a trumpet, and therefore the tool isreferred to herein as a “trumpet punch” or “hybrid trumpet punch.”

This disclosed tubular tool is commonly called a punch and is classifiedto under a very limited group of hybrid punches that are not very sharp.In one aspect of the disclosed technology, the punch is driven by adedicated system that includes a foot pedal and a motor. This pedalactivates the motor, which is coupled to the punch. This pedal producesmovement of the motor and, therefore, movement of the punch. The pedalis not a simple on-off switch. Rather it triggers an oscillatoryrotation whose speed is proportional to the pedal stroke.

In one aspect of the disclosed technology, An apparatus for harvestinghair grafts from an epidermis includes a hollow tubular structure havinga central axis and a trumpet bell structure attached to an end of thehollow tubular structure. The trumpet bell structure terminates at aflat annular face that is substantially in a plane perpendicular to thecentral axis. The flat annular face has a sharp outer edge, and an innersurface of the trumpet bell structure inward from the flat annular faceis smoothly varying.

In one embodiment, the flat annular face is at an angle relative to thecentral axis of 85° to 95° or 87° to 93° and is not perpendicular to thecentral axis. In one embodiment, the flat annular face is perpendicularto the central axis. In one embodiment, the flat annular face has athickness of 50 μm or more. In one embodiment, the flat annular face hasa thickness of 80 μm or 100 μm or more. In one embodiment, the hollowtubular structure has an outer diameter between 0.7 mm and 1.4 mm and awall thickness between 50 μm and 150 μm. The sharp outer edge of theflat annular face of the trumpet bell structure has an outer diameterthat is greater than the outer diameter of the hollow tubular structureby at most 200 μm. In one embodiment, the hollow tubular structureincludes one or more windows.

In one embodiment, the trumpet bell structure has a height of less than1000 μm. In one embodiment, the trumpet bell structure has a height ofless than 500 μm. In one embodiment, the trumpet bell structure has aheight between 300 μm and 500 μm.

In one embodiment, the inner surface of the trumpet bell structureinward from the flat annular face is substantially shaped as a halfcatenoid. In one embodiment, the sharp outer edge of the trumpet bellstructure has a toothed configuration having one or more teeth. In oneembodiment, the sharp outer edge of the trumpet bell structure issubstantially circular.

In one aspect of the disclosed technology, the disclosed apparatusincludes a motor coupled to the trumpet bell structure that causes thetrumpet bell structure to rotate successively between clockwise andcounterclockwise rotations. In one embodiment, the motor is capable ofbeing controlled to vary an amount of rotation of the trumpet bellstructure such that each clockwise or counterclockwise rotation iscapable of rotating more than 30° but less than 360°.

In one aspect of the disclosed technology, the disclosed apparatusincludes a pedal coupled to the motor. In one embodiment, the pedalcontrols rotation of the trumpet bell structure such that a depressionof the pedal corresponds to a proportional change in a speed of therotation of the trumpet bell structure. In one embodiment, a depressionof the pedal corresponds to an exponential increase in a speed of therotation of the trumpet bell structure. In one aspect of the disclosedtechnology, the pedal is configurable to adjust the exponentialcorrelation between the depression of the pedal and the increase in thespeed of the rotation of the trumpet bell structure, and the pedal isconfigurable to select among two or more exponential correlations. Inone aspect of the disclosed technology, the speed of the rotation of thetrumpet bell structure is adjustable between 60clockwise-counter-clockwise rotations per minute and 300clockwise-counter-clockwise rotations per minute.

In one embodiment, the apparatus includes a battery powering the motor,and the pedal is coupled to the motor wirelessly. In one embodiment, theapparatus includes a battery powering the pedal. In one embodiment, thepedal includes a visual indicator that provides a warning before thebattery is completely depleted.

In one embodiment, the apparatus includes a robot for assisting surgicalhair transplantation, and the hollow tubular structure and the trumpetbell structure are coupled to the robot. In one embodiment, theapparatus includes a dental handpiece, and the hollow tubular structureand the trumpet bell structure are coupled to the dental handpiece.

In one aspect of the disclosed technology, the apparatus includes asuction chamber attached to the end of the hollow tubular structureopposite the trumpet bell structure and a suction device is coupled tothe suction chamber.

In one aspect of the disclosed technology, the apparatus includes a sizeindicator which indicates a size of the trumpet bell structure. In oneaspect of the disclosed technology, the apparatus includes a pluralityof depth indicators on the hollow tubular structure which indicate depthat which the trumpet bell structure has been inserted below anepidermis.

In one aspect of the disclosed technology, an apparatus for harvestingto hair grafts from an epidermis includes a hollow tubular structurethat terminates at a rounded base. The base is substantiallyperpendicular to a central axis of the hollow tubular structure. Anannular lip surrounds the end portion of the hollow tubular structure.The annular lip has an annular ledge that is substantially perpendicularto an outer surface of the hollow tubular structure. The annular lipalso has a transition portion that smoothly connects the annular ledgeto the rounded base of the hollow tubular structure. In one embodiment,the transition portion is at an angle relative to the central axis of30° to 60°.

In one embodiment, the tool can be housed in a handpiece or device usedin the dental industry and can be capable of being sterilized. Thedisclosed technology can decrease the transection of follicles, i.e.,the partial or complete cut of one or more hairs composing thisfollicle, and thus greatly improve the quality of the FUE hairtransplant surgery and the number of harvested grafts. The number ofmissing grafts, that is to say, the number of grafts completelytransected or buried in the skin, therefore, decreases dramatically.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows a follicle model with its classic conicalshape.

FIG. 2 shows examples of sharp punches according to Dr. John Cole andArtas.

FIG. 3 shows an example of an extracting device according to Dr. JamesHarris comprising a handle, a sharp punch on one side of the handle, andan extraction punch on the other side of the handle.

FIG. 4 shows an example of a tool from Restoration Robotics with twopunches slidably mounted.

FIG. 5 shows an example of use of a tool according to the disclosedtechnology, during the epidermis-cutting step.

FIG. 6 shows exemplary views of a tool according to one embodiment ofthe disclosed technology.

FIG. 7 shows exemplary views of a tool according to another embodimentof the disclosed technology, in which windows are provided in the tool.

FIG. 8 shows exemplary views of a tool according to the disclosedtechnology in which teeth are provided on the outside rim of the trumpetpunch.

FIG. 9 shows a comparison of a punch according to the disclosedtechnology and a punch according to Dr. Sanusi Umar.

FIG. 10 shows a comparison of a punch according to the disclosedtechnology and punches according to Dr. James Harris.

FIG. 11 shows examples of cross-sections of trumpet punches according toembodiments of the disclosed technology.

FIG. 12 shows an example of a suction system external to the punch, inaccordance with aspects of the disclosed technology.

FIG. 13 shows examples of a pedal equipped with various control buttons,in accordance with aspect of the disclosed technology.

FIG. 14 shows examples of correlation between pedal pressure and motorspeed, in accordance with different embodiments of the disclosedtechnology.

FIG. 15 shows exemplary views of a tool according to another embodimentof the disclosed technology.

DETAILED DESCRIPTION

The disclosed technology relates to hair follicle harvesting system,method, and apparatus that greatly reduces the rate of transection andmissing grafts, even when using smaller diameter punches, and thatincreases harvesting rate with little or no damage to follicles duringthe extraction step. The system includes various parts. In particular, apedal activates a motor, which communicates therewith via a cable orwirelessly. A handpiece can be fitted to the motor, and the pedaltriggers movement of a punch held in the handpiece via a chuck.

A tool according to the disclosed technology combines in a single punchtwo seemingly opposing characteristics: a punch sharp enough topenetrate the epidermis easily and at the same time ensuring that thispunch is sufficiently gentle so as to reduce damage to the hairs when itplunges into the dermal portion of the skin.

In accordance with one aspect of the disclosed technology, the disclosedtool positions an annular cutting edge at the outer perimeter of the endof the tool and places it in a plane perpendicular to the central axisof the punch. A tool according to one embodiment of the disclosedtechnology has a hollow tubular structure with a central axis and an endstructure in the shape of a trumpet bell. The trumpet bell structureterminates in a substantially flat and ring-like/annular face extendingsubstantially in a plane perpendicular to the central axis. Thesubstantially flat annular face has a sharp outer edge, which can becontinuous and substantially circular, or can be non-circular and jaggedor tooth-like.

The operation of the tool according to the disclosed technology is shownin FIG. 5, which illustrates a cross-section of a hollow tubularstructure 502 and a trumpet bell structure 504 of one embodiment of thedisclosed punch. The trumpet bell structure 504 is shaped such that itappears as a funnel to the hair. The cutting edge 506 is located on theouter edge of the flat annular face 508 of the trumpet bell structureand is located in a plane that is perpendicular to the central axis A ofthe hollow tubular structure 502.

If this trumpet-shaped end structure is placed perpendicularly to theepidermis, the flat face 508 of the tool is supported on the skin insuch a way that the rotation of the tool relative to its central axis inno way cuts the epidermis. On the other hand, if one pivots the tool sothat its end portion is positioned in a plane at an angle of 30 to 60°with respect to the plane of the epidermis, the sharp outer edge 506 isin contact with the epidermis and is capable of marking and cutting theskin during a rotary movement of the tool about its central axis.

A punch according to the disclosed technology is positioned such thatthe skin is not approached perpendicularly but obliquely. The sharpouter edge 506 of the end of the punch can therefore easily cut into theepidermis, which, as previously described, can be resistant. Once thisbarrier is passed, the movement of the punch can be controlled in orderto move it parallel to the axis of the hairs, and therefore the cuttingportion (outer edge) also moves in such a way that it is remote from thehair to be harvested and therefore cannot damage the hairs/grafts thatare harvested. In addition, these hairs are directed towards the centerof the punch, as in a funnel, and touch the round inner portion of thepunch, as shown in FIG. 5, which greatly reduces, or even eliminates,their transection and also reduces the damage that sharp punches usuallycause.

Because the disclosed punch has both sharp and unsharp characteristics,they are referred to herein as “hybrid trumpet punches.” Because theinside of the punch is smooth, it is possible to reduce the size of thepunch used, and thus to reduce the injuries/scars around the hairs.

In one aspect of the disclosed technology, movement of the punch is aslow movement between approximately 60 and 300 revolutions per minute.In one embodiment, the movement is an oscillating movement such thatrotation successively changes direction after having travelled a 30 and360 degree course. The pedal which is included in the disclosed system(discussed below herein) allows one to change the speed of this movementwith more or less pressure on the foot pedal.

The disclosed punch operates to harvest intact human follicular unitsduring a hair transplant surgery. The disclosed harvesting tool has someof the beneficial characteristics of conventional sharp punches withoutbeing a sharp punch.

Referring to FIG. 6, the hybrid trumpet punch according to the disclosedtechnology can be a single piece that is made from the stainless steel.It can include two hollow tubular structures. The wider proximal tubularstructure (T1) can have an outer diameter of approximately 2.34 mm,which makes it compatible to fit in most dental handpieces. In oneembodiment, the wider proximal tubular structure can serve as a suctionchamber and can be housed in a dental handpiece that provides suction.In one embodiment, the hybrid trumpet punch can be housed in a dentalhandpiece that does not provide suction, and suction can be providedseparately from the handpiece.

The disclosed tool includes a narrower, distal hollow tubular structure(T2) with a central axis and an end structure 3 in the shape of atrumpet bell. The trumpet bell terminates with a substantially flat andannular/ring-like face 4 that extends substantially in a planeperpendicular to the central axis of the punch and having a sharp outeredge 5. In one embodiment, the sharp outer edge 5 can be substantiallycircular and continuous. In one embodiment, the sharp outer edge 5 canbe non-circular and can include one or more teeth.

Referring to FIGS. 6-12, a tool according to the disclosed technologyhas one or more of the following features. The tool includes a centralaxis, while the substantially flat and annular face 4 at the baseportion of the tool, which is configured to be at an angle relative tothe central axis that is between 85 to 95°, as shown in FIG. 11. In oneembodiment, the angle can be between 87° to 93°. In one embodiment, theflat annular face 4 can be perpendicular to the central axis, as shownin FIG. 6.

In one embodiment, the substantially flat, annular or ring-like face 4has a wall thickness between 50 μm and 100 μm, which is the differencebetween ExTr and IntTr. In one embodiment, the hollow tubular structureT2 has an external diameter ExDi between 0.7 mm and 1.4 mm and has awall thickness between 50 and 150 μm. In one embodiment, the externaldiameter ExTr at the end of the trumpet bell structure is greater thanthe outer diameter ExDi of the hollow tubular structure T2 byapproximately 50 to 150 μm. In one embodiment, the external diameterExTr at the end of the trumpet bell structure is greater than the outerdiameter ExDi of the hollow tubular structure T2 by no more than 200 μm.

In one embodiment, the inner edge 10 (InTr) of the flat annular face 4of the trumpet bell structure is substantially aligned with the outersurface of the hollow tubular structure T2 with diameter ExDi.Accordingly, the inner edge 10 of the flat annular face 4 of the trumpetbell structure IntTr therefore has a diameter equal to or close to thediameter ExDi.

In one embodiment, the trumpet bell shaped structure 3 has a length ofless than 1000 μm. In one embodiment, the trumpet bell shaped structure3 has a length between 500 and 300 μm.

With continuing reference to FIG. 6, the trumpet bell structure 3 has asmoothly curved inner surface 6 that smoothly connects to the innersurface of the hollow tubular structure T2. In one embodiment, the innersurface 6 of the trumpet bell structure 3 is substantially in the shapeof a half catenoid.

In one embodiment, the outer edge 5 of the flat annular face 4 of thetrumpet bell structure is sharp. The flat annular face 4 can be beveledto enhance the sharpness of the outer edge. The inner edge 10 of theflat annular face 4 of the trumpet bell structure can have a less abruptangle or can be rounded.

Referring now to FIG. 7, the hollow tubular structure may have one ormore windows 8 that provide a view of the hair to be harvested withinthe hollow tubular structure. In the illustrated embodiment of FIG. 7,two windows 8 opposite each other and positioned 180 degrees apart arearranged on the lower part 2 of the hollow tubular structure just abovethe trumpet bell structure.

The windows of FIG. 7 provide two advantages. As mentioned above, thewindows allow a view of the hair and thus allow a user to accuratelyposition the punch around the hairs. Secondly, friction between thehairs and the punch is reduced due to decreased inner surface areabecause of the windows, thereby allowing the punch to be driven deeperinto the dermis while avoiding a phenomenon known as the “missing graft”(graft failure). A missing graft can occur when a conventional punch isinserted too deeply and causes twisting of the follicle, which can leadto a shortening of the latter and to “suction” inside the skin. Thegraft can disappear completely from the operating field, and it isvirtually impossible to recover it.

FIG. 8 shows another embodiment of the disclosed tool. In theillustrated embodiment, the tool can include teeth arranged on the outersurface of the hollow tubular structure 2 and/or on the outer surface ofthe trumpet bell structure 3. In one embodiment, the outer surface caninclude between 20 to 30 teeth. The illustrated toothed punch can beused when the skin resistance is particularly significant. Theembodiments of FIGS. 7 and 8 can be separate, as illustrated, or can becombined such that a tool can have both windows and teeth.

Referring now to FIG. 12, the disclosed technology can include a suctionchamber T1 attached to the hollow tubular structure T2. This suctionchamber can be connected to a pump (not shown). When the punch is housedin a handpiece, the pump can be located away from the handpiece orattached to the handpiece. This suction can aspirate the blood thatpools in the holes made in the skin. This also allows lightly suctioningthe follicle during extraction and securing it by preventing it fromrotating inside the punch.

Referring to FIGS. 6-8, in one aspect of the disclosed technology, sizeindicators such as line or circular markings can be affixed to the outersurface of the wider tubular structure T1 to indicate the size of thepunch to the operator. Such size can correspond to the outer diameter ofthe flat annular face of the trumpet bell structure (ExTr). It,therefore, corresponds to the actual size of the hole created by thedistal part of the narrower tubular structure (T2). In accordance withthe disclosed technology, the hybrid trumpet punches can have thefollowing sizes: size 1: 0.7 mm; size 2: 0.75 mm; size 3: 0.8 mm; size4: 0.85 mm; size 5: 0.9 mm; size 6: 0.95 mm; size 7: 1 mm size 8: 1.05mm; size 9: 1.1 mm; size 11: 1.2 mm. Other sizes not expressly statedherein are contemplated and are encompassed by the disclosed technology.

In one aspect of the disclosed technology, the thickness of the tubularstructure wall is adapted to its diameter. In one embodiment, the wallthickness can range from 0.08 mm (80 μm) and 0.12 mm (120 μm).

For example, a punch of 0.9 mm will have an external diameter of 0.9 mmfor face of the trumpet bell structure. Correspondingly, the hollowtubular structure T2 will have an inner diameter of 0.75 mm and an outerdiameter of 0.9 mm.

In one aspect of the disclosed technology, and referring to FIGS. 6-8,the tubular structure T2 can include depth indicators 20, such asgraduated markings, that indicate the depth at which the punch islocated below the surface of the skin. In one embodiment, a marking canbe placed every 500 m along the outer surface of the tubular structureT2.

Referring to FIG. 7, the windows 8 can be positioned just above thetrumpet bell structure and the size of the windows can depend on thesize of the tubular structure T2. For example, the size of the windows 8can increase with the diameter of the tubular structure T2. For examplea punch of size 0.9 mm can have two windows of size 3 mm by 0.6 mm.

What has been described above herein is a tool for harvesting follicleshaving a tubular structure attached to a trumpet bell structure. In oneembodiment, as illustrated in FIG. 9, the hollow tubular structure T2can have a constant inner and outer diameter and a constant wallthickness. This disclosed tool differs from punches disclosed by Dr.Umar Sanusi, which have varying inner and/or outer diameters.Furthermore, the punches of Dr. Umar are sharp punches whose cuttingedges are not substantially perpendicular to the central axis of thepunch. The disclosed trumpet punch, in contrast, has a cutting edge thatis substantially perpendicular to the central axis of the punch.

In one embodiment, as illustrated in FIG. 10, the disclosed trumpet bellstructure 3 flares outward from the hollow tubular structure T2 to whichit is attached, and the annular face 4 of the trumpet bell structure issubstantially circular. This disclosed tool differs from punchesdisclosed by Dr. James Harris, which taper inward at the end or do nottaper at all at the end.

What will now be described is another embodiment of a tool in accordancewith the disclosed technology. Referring to FIG. 15, the illustratedtool includes a tubular structure T2 that terminates at an end 1502 witha rounded annular face. Surrounding the end portion is an annular lip1504 that includes an annular ledge 1506. In one embodiment, the ledge1506 is perpendicular to the central axis of the hollow tubularstructure T2. The outer edge 1508 of the ledge can connect smoothly withthe rounded annular face 1502 of the end of hollow tubular structuresuch that the end 1502 of the disclosed tool remains rounded and smooth.Various aspects of the tools illustrated in FIGS. 6-8 are applicable tothe punch of FIG. 15, including, for example, various dimensions ofwalls and diameters, such as the wall thickness between ExDi and InDi.For example, the annular ledge can have a diameter ExUm that is greaterthan the diameter ExDi of the hollow tubular structure by no more than100 to 200 μm.

What will now be described in connection with FIGS. 13 and 14 are partsof the disclosed tool motorizing the disclosed punch. FIG. 13 is anillustration of a foot pedal 1300 in accordance with one embodiment ofthe disclosed technology. The pedal includes a top plate 1302 whichpivots and can travel a distance of, for example, 5 cm. The pedal cancontrol rotation of the disclosed punch through a motor (not shown), andthe depression of the pedal top plate 1302 enables the rotational speedof the punch to be varied with precision. Outlet B provides a port orjack or connection through which the foot pedal can communicate with andpower the motor for rotating the disclosed punch. In another embodiment,the foot pedal can communicate wirelessly with the motor, such as byBluetooth or another wireless protocol, and the motor can have aseparate power source.

In one embodiment, the pedal 1300 can include various knobs or buttonsor interfaces, each having different functions, as described in thefollowing disclosure.

In one embodiment the foot pedal 1300 can be powered by a battery (notshown). The first button A, located below the pedal, allows powering ofthe motor only when the pedal is actively used. In other words, button Aserves to prevent powering of the motor when the pedal is not activelyused. In this way, the battery is very slightly discharged when the footpedal 1300 is not actively used. In this manner, the batteries canoperate for extended periods without recharging. In one embodiment, thebattery can provide power for 72 hours without recharging.

In the illustrated embodiment, there foot pedal 1300 can provide anindication that the battery will be imminently discharged, whichprovides a degree of protection against the complete discharge ordepletion of the batteries. In one embodiment, a red flashing button(not shown) can warn of impending discharge or depletion of the batteryand can notify a user to charge the batteries. In one embodiment, thebatteries can be recharged with a charger (not shown) that plugs intothe socket F. The plug can be compatible with all regions of the world.

In the illustrated embodiment, button C enables the very precise of theamount of angular rotation of the punch. In one embodiment, thedisclosed punch can rotate around its axis alternating successivelybetween clockwise rotation and counter-clockwise rotation. In oneembodiment, each clockwise rotation or counter-clockwise rotation can bebetween 30° and 360°, and button C is used to adjust the number ofdegrees of this angular rotation in each direction. In some embodiments,the angular rotation can be more than 360°.

In one aspect of the disclosed technology, the rotation speed or angularvelocity of the punch can be controlled. With reference also to FIG. 14,the illustrated graph shows that displacement of the foot pedal canincrease the angular velocity of the punch rotation exponentiallydepending on the intensity of the thrust on the pedal. The foot pedalcan include different correlations between pedal pressure and the motordriving the rotation of the punch, as illustrated. Knob D, illustratedin FIG. 13, can be used to modify the correlation or progression curve.In one embodiment, turning the knob D clockwise straightens the curve(for example, 1 towards 2 towards 3) which allows for greaterresponsiveness of the pedal.

In one embodiment, button E allows adjusting the level of the initialstarting speed of the motor. It does not alter the progression of themotor speed as shown in FIG. 14 and is a separate functionality. ButtonE can be set at the first use and need not be set again unless adifferent motor is connected.

Accordingly, what has been described above herein is a pedal, activatedby the operator's foot, which launches the rotation of the punch andcontrols it in a precise manner. In use, the disclosed system can limitthe movements of the punch when necessary. When piercing the epidermisas shown in FIG. 5, a speed between 60 and 300clockwise-counter-clockwise rotations per minute can be achieved withthe disclosed system. Then, when the punch penetrates into the deepdermis, the rotational speed can be decreased further. The disclosedsystem also allows, via the adjusting knobs, to change the amount ofangular rotation in order to minimize the twisting of the follicle,which results from friction between the graft and the inner part of thepunch. The recommended amount of angular rotation in the clockwisedirection and the counter-clockwise direction is between 30° and 360°,depending on the quality of the skin. It is common to successfullyextract a graft with a succession of about a dozen clockwise andcounter-clockwise oscillations.

The disclosed pedal can include circuitry, processors, microcontrollers,programmable logic devices. ASICS, memory, software, firmware, and/orother software or hardware to perform the disclosed operations. Thedisclosed buttons and knobs on the pedal are exemplary and otherinterfaces are contemplated, such as switches, slides, and touchscreens.

A punch in accordance with the disclosed technology is capable ofextracting between 500 and 1000 grafts before requiring light sharpeningand between 4000 and 8000 grafts before being replaced.

A punch according to the disclosed technology can be driven much deeperthan a sharp punch of an equivalent diameter, with lesser risk ofdamage. This penetration depth may be equal to the length of a hairfollicle, such as between 3 and 5 mm. The result is the ability toobtain high quality grafts, with very low transection rate and, at thesame time, a higher number of hairs per graft (follicular density) thanwith a sharp punch of the same diameter. Additionally, the actualextraction step is facilitated because the attachments of thesurrounding tissue are more deeply broken than with a sharp punch, whichoperates more superficially. The disclosed system operates significantlyfaster than prior systems. Even if the actual cutting step may, in somecases, be slightly slower than with “sharp” punches, the shortening ofthe extraction step shortens the total extraction operating time. Withprior systems, an experienced practitioner can extract up to 600 graftsper hour when the extraction step is separated from the cutting step(that is to say, the cutting step carried out with the punch comes to astop during the extraction step with another tool or part of a tool). Incontrast, the tool according to the disclosed technology can permithourly follicular extraction rates of around 1000 grafts per hour.

The use of the disclosed hybrid trumpet punch can be particularlyeffective in cases that are generally difficult to treat. These includeextraction of old grafts that are too voluminous, of hair grafts inAfrican patients, and of beard grafts.

In the first case, the hair is often spaced further apart from eachother than in a conventional situation. Furthermore, the internalmicro-scars increase the strength of the attachment of the hair to thesurrounding tissue. Among African patients, the hairs are highly curvedin the shape of commas and their extraction is often extremelydifficult, if not impossible, with the conventional technique of sharppunches. Finally, as to beard hairs, the hairs extracted almost neverhave lesions.

Those skilled in the art will recognize that the disclosed embodimentsare illustrative and do not limit the scope of the disclosed technology.It is contemplated that various embodiments can be combined. The scopeof the disclosed technology will be defined by the claims, which areappended hereto.

What is claimed is:
 1. An apparatus for harvesting hair grafts from anepidermis, the apparatus comprising: a hollow tubular structure having acentral axis; and a trumpet bell structure attached to an end of thehollow tubular structure and terminating at a flat annular face that issubstantially in a plane perpendicular to the central axis, wherein theface has a sharp outer edge and wherein an inner surface of the trumpetbell structure inward from the flat annular face is smoothly varying,wherein each portion of the flat annular face is at an angle relative tothe central axis of 85° to 95°.
 2. The apparatus according to claim 1,the flat annular face being perpendicular to the central axis.
 3. Theapparatus according to claim 1, wherein the flat annular face has athickness of at least 50 μm.
 4. The apparatus according to claim 3,wherein the flat annular face has a thickness of at least 100 μm.
 5. Theapparatus according to claim 1, wherein the hollow tubular structure hasan outer diameter between 0.7 mm and 1.4 mm and a wall thickness between50 μm and 150 μm, and wherein the sharp outer edge of the flat annularface of the trumpet bell structure has an outer diameter that is greaterthan the outer diameter of the hollow tubular structure by at most 200μm.
 6. The apparatus according to claim 1, wherein the trumpet bellstructure has a height of less than 1000 μm.
 7. The apparatus accordingto claim 6, wherein the trumpet bell structure has a height of less than500 μm.
 8. The apparatus according to claim 1, wherein the inner surfaceof the trumpet bell structure inward from the flat annular face issubstantially shaped as a half catenoid.
 9. The apparatus according toclaim 1, wherein the hollow tubular structure includes one or morewindows.
 10. The apparatus according to claim 1, wherein the sharp outeredge of the trumpet bell structure has a toothed configuration havingone or more teeth.
 11. The apparatus according to claim 1, wherein thesharp outer edge of the trumpet bell structure is substantiallycircular.
 12. The apparatus according to claim 1, further comprising amotor coupled to the trumpet bell structure that causes the trumpet bellstructure to rotate successively between clockwise and counterclockwiserotations.
 13. The apparatus according to claim 12, wherein the motor iscapable of being controlled to vary an amount of rotation of the trumpetbell structure, wherein each clockwise or counterclockwise rotation iscapable of rotating more than 30° but less than 360°.
 14. The apparatusaccording to claim 12, further comprising a pedal coupled to the motor,the pedal controlling rotation of the trumpet bell structure, wherein adepression of the pedal corresponds to a proportional change in a speedof the rotation of the trumpet bell structure.
 15. The apparatusaccording to claim 14, wherein the speed of the rotation of the trumpetbell structure is adjustable between 60 clockwise-counter-clockwiserotations per minute and 300 clockwise-counter-clockwise rotations perminute.
 16. The apparatus according to claim 14, further comprising abattery powering the motor, wherein the pedal is coupled to the motorwirelessly.
 17. The apparatus according to claim 14, further comprisinga battery powering the pedal, wherein the pedal comprises a visualindicator that provides a warning before the battery is completelydepleted.
 18. The apparatus according to claim 12, further comprising apedal coupled to the motor, the pedal controlling rotation of thetrumpet bell structure, wherein a depression of the pedal corresponds toan exponential increase in a speed of the rotation of the trumpet bellstructure.
 19. The apparatus according to claim 18, wherein the pedal isconfigurable to adjust the exponential correlation between thedepression of the pedal and the increase in the speed of the rotation ofthe trumpet bell structure, the pedal being configurable to select oneof at least two exponential correlations.
 20. The apparatus according toclaim 1, further comprising a robot for assisting surgical hairtransplantation, the hollow tubular structure and the trumpet bellstructure being coupled to the robot.
 21. The apparatus according toclaim 1, further comprising a dental handpiece, the hollow tubularstructure and the trumpet bell structure being coupled to the dentalhandpiece.
 22. The apparatus according to claim 1, further comprising: asuction chamber attached to an end of the hollow tubular structureopposite the trumpet bell structure; and a suction device coupled to thesuction chamber.
 23. The apparatus according to claim 1, furthercomprising a size indicator which indicates a size of the trumpet bellstructure.
 24. The apparatus according to claim 1, further comprising aplurality of depth indicators on the hollow tubular structure whichindicate depth at which the trumpet bell structure has been insertedbelow an epidermis.